Non-invasive surgical ligation clip system and method of using

ABSTRACT

A surgical ligation clip capable of remote deployment through a cannula to engage an anatomical structure.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation application of U.S. application Ser.No. 10/215,216, filed on Aug. 8, 2002 by Michael S. Rosenberg et al. andentitled “NON-INVASIVE SURGICAL LIGATION CLIP SYSTEM AND METHOD OFUSING.” The disclosure of this earlier application is fully incorporatedherein by reference.

FIELD OF THE INVENTION

The invention relates to ligation clips used in non-invasive surgicalprocedures.

BACKGROUND

Non-invasive surgical procedures are increasingly popular amongphysicians, patients and insurance companies due to the decreased traumaand consequent healing time to the patient and decreased overall costresulting from shortened hospital stays. Such surgical procedures allowphysicians to access remote regions of a patient's body to performsurgery without having to make major incisions in the patient's body.One form of non-invasive procedure requires the physician to createsmall incisions proximate the area underlying which the procedure is tobe performed. Often, several such minor incisions are created, throughwhich the physician inserts fiber optic viewing systems and microinstruments able to perform the procedure. In another type of procedure,the interior of the body is accessed by means of navigating viewingsystems and instruments through the vasculature of the patient to theinternal treatment site, following which, the procedure is performed. Inboth types of procedures, it is often necessary for the physician to beable to ligate blood vessels that may be intentionally or inadvertentlysevered. Additionally, clamping off of aneurysms and fistulas may alsobe required.

Existing systems for ligating during non-invasive surgery include adevice for remotely applying surgical conventional stainless steelstaples, as disclosed in U.S. Pat. No. 5,403,327, to Thronton et al.Such a system is, however, limited, to a rigid-shafted, straight-lineinstrument, and thus is inapplicable to many procedures where a moretortuous introductory path is required to access the treatment site. Afurther disadvantage of stainless steel clips deals with the relativelylow elasticity of stainless steel, which, when sufficiently bent, tendsto remain in its bent position. Thus, repositioning the clip afterinitial placement using the system in Thronton et al. is impossiblewithout further open surgery. U.S. Pat. No. 6,001,110, to Adams,proposes a hemostatic clip constructed of nitinol that is superelasticat human body temperatures. The Adams clip, in one embodiment, istrained to be in a “U” configuration when in an undeformed state. Priorto application of the Adams clip, its prongs are forced open against itstrained inward tendency, the clip is navigated proximate the structureto be clamped, and then the prongs are released around the structure.The structure is clamped off, resulting from the prongs attempting toreturn to their original inward position, restrained only by the tissuebeing clamped. The Adams device is limited to a rigid, straight-linehypotube delivery system, restricting the uses to which it may bedirected. What is clearly needed, therefore, is a surgical ligating clipthat can be navigated via the patient's vascular system to remote sitesin the patient's body and installed. Additionally desirable would be theability to reposition the clip following initial placement.

SUMMARY OF THE INVENTION

In one embodiment, the invention comprises a clip defining an unstressedshape. A first opposing jaw defines a clamping portion and a secondopposing jaw defines a clamping portion. At least the first jaw definesa flexing portion having a different shape than the clamping portion ofthe first jaw, and the flexing portion is capable of being stressed soas to alter its shape and then resuming the unstressed shape when nolonger being stressed. The first and second jaws are unattached at afirst point of the clamping portions of the first and second jaws, whichallows the first and second jaws to be able to separate apart from eachother. When the flexing portion of the first jaw is stressed so as toalter its shape, the clamping portion of the first jaw moves in relationto the clamping portion of the second jaw. This causes the clampingportion of the first jaw to separate from the clamping portion of thesecond jaw.

In another embodiment, the invention comprises a clip defining anunstressed shape. The clip includes first and second opposing,longitudinally configured jaws, with the first and second jaws eachdefining a clamping portion and a flexing portion. The flexing portionsare capable of being stressed so as to alter the unstressed shape of theflexing portions and then resuming he unstressed shape when the clip isno longer being stressed. The first and second jaws are unattached at afirst point of the clamping portions which allows the first and secondjaws to be able to separate apart from each other. Stressing the flexingportions of the first and second jaw toward each other therefore causesthe clamping portions of the first jaw and second jaw to move away fromeach other.

In yet another embodiment, the invention comprises a clip system. Thesystem comprises a clip having a lateral dimension and a longitudinaldimension. The clip further defines an unstressed shape. A firstopposing jaw defines a clamping portion and a second opposing jawdefines a clamping portion. At least the first jaw defines a flexingportion having a different shape than the clamping portion of the firstjaw, and the flexing portion is capable of being stressed so as to alterits shape and then resuming the unstressed shape when no longer beingstressed. The first and second jaws are unattached at a first point ofthe clamping portions of the first and second jaws, which allows thefirst and second jaws to be able to separate apart from each other. Whenthe flexing portion of the first jaw is stressed so as to alter itsshape, the clamping portion of the first jaw moves in relation to theclamping portion of the second jaw. This causes the clamping portion ofthe first jaw to separate from the clamping portion of the second jaw.The system also comprises a cannula. The cannula includes a tubularmember defining walls and a lumen, and a proximal end and a distal end.The lumen has a sufficient inner dimension to accommodate the clip whenthe flexing portion of the first jaw is stressed toward the second jaw,thus reducing the lateral dimension of the clip and increasing thelongitudinal dimension of the clip. This allows the flexing portion ofthe first jaw to be stressed to reduce the lateral dimension to besmaller than the inner dimension of the lumen of the cannula. Followingstressing of the clip it is loaded into the lumen so that the clampingportion faces the distal end of the cannula, which constrains theflexing portion and the clamping portion within the cannula. Advancingthe clamping portions of the first and second jaws of the clip from thedistal end of the cannula results in the clamping portions of the firstand second jaws spreading apart from each other as long as the flexingportion of the first jaw remains constrained within the lumen of thecannula. Further advancing the clip from the distal end of the cannulaso that the flexing portion of the first jaw is released from thecannula results in the clamping portions of the first and second jawsattempting to resume the unstressed, parallel configuration.

A further embodiment of the invention comprises a clip system. Thesystem comprises a clip defining an unstressed shape. The clip includesfirst and second opposing, longitudinally configured jaws, with thefirst and second jaws each defining a clamping portion and a flexingportion. The flexing portions are capable of being stressed so as toalter the unstressed shape of the flexing portions and then resuming heunstressed shape when the clip is no longer being stressed. The firstand second jaws are unattached at a first point of the clamping portionswhich allows the first and second jaws to be able to separate apart fromeach other. Stressing the flexing portions of the first and second jawtoward each other therefore causes the clamping portions of the firstjaw and second jaw to move away from each other. The system alsocomprises a cannula. The cannula includes a tubular member definingwalls and a lumen, and proximal and a distal ends. The lumen has asufficient inner dimension to accommodate the clip when the flexingportion of the first jaw is stressed toward the second jaw, thusreducing the lateral dimension of the clip and increasing thelongitudinal dimension of the clip. The flexing portions of the firstand second jaw are stressed to reduce the lateral dimension to besmaller than the inner dimension of the lumen of the cannula and theclip is loaded into the lumen so that the clamping portion faces thedistal end of the cannula, which constrains the flexing portion and theclamping portion within the cannula. Advancing the clamping portions ofthe first and second jaws of the clip from the distal end of the cannularesults in the clamping portions of the first and second jaws spreadingapart from each other as long as the flexing portions of the first andsecond jaws remain constrained within the lumen of the cannula. Furtheradvancing the clip from the distal end of the cannula so that theflexing portions of the first and second jaws are released from thecannula results in the clamping portions of the first and second jawsattempting to resume the unstressed, parallel configuration.

In yet a further embodiment, the invention comprises a method of using aclip system. The method includes the step of providing a clip systemcomprising a clip having a lateral dimension and a longitudinaldimension. The clip defines an unstressed shape. A first opposing jawdefines a clamping portion and a second opposing jaw defines a clampingportion. At least the first jaw defines a flexing portion having adifferent shape than the clamping portion of the first jaw, so theflexing portion is capable of being stressed so as to alter its shapeand then resume the unstressed shape when no longer being stressed. Thefirst and second jaws are unattached at a first point of the clampingportions of the first and second jaws, which allows the first and secondjaws to be able to separate apart from each other. When the flexingportion of the first jaw is stressed so as to alter its shape, theclamping portion of the first jaw moves in relation to the clampingportion of the second jaw, separating the clamping portion of the firstjaw from the clamping portion of the second jaw. Determining a structurerequiring clamping is necessary as is navigating the clip system to aremote internal area of a patient's body. When the clip system isnavigated to the remote area of a patient's body, the clip is advanceddistally from the cannula toward the structure requiring clamping sothat the clamping portions of the clip are spread apart from each other.The clip is further distally advanced to move the spread apart clampingportions of the clip around the structure to be clamped. Finally, theclip is further distally advanced from the cannula so that the flexingportions of the jaws are advanced distally from the cannula to allow theflexing portions to resume their non-stressed shape, resulting in theclamping portions of the jaws returning toward their non-stressedparallel configuration, resulting in clamping of the desired structure.Following initial placement, if repositioning of the clip is necessaryor desired, the clip is withdrawn in a proximal direction into thecannula a sufficient distance to stress the flexing portions of thefirst and second jaws. This results in spreading apart the clampingportions of the first and second jaws and the unclamping of theinitially clamped structure. The clip is then repositioned and the firstand second jaws are again advanced in a distal direction from thecannula allowing the clamping portions of the first and second jaws toclamp the structure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of the ligation clip.

FIG. 2 shows a top view of the ligation clip shown in FIG. 1.

FIG. 3 shows a side view of an alternative embodiment of the ligationclip.

FIG. 4 shows a perspective view of a further alternative embodiment ofthe ligation clip.

FIG. 4 a shows a cross section taken along line A-A of the clampingportion of the clip shown in FIG. 4, including the “D” shaped wire fromwhich it is made.

FIG. 5 shows a side cutaway view of the ligation clip loaded into acannula.

FIG. 6 shows the clip advanced from the cannula so the jaws are opened.

FIG. 7 shows a the clip further advanced from the cannula so that thejaws after surrounding the vessel attempt to close resulting inocclusion of the clamped vessel.

FIG. 8 shows a side view of the ligation clip completely emerged fromthe cannula.

FIG. 9 shows a side view of the ligation clip having wavy, interlockinginner edges on the clamping portions of the jaws.

FIG. 10 shows a side view of an embodiment of the ligation clip havingone jaw with a flexing portion.

FIG. 11 shows a side view of an alternative embodiment of the ligationclip.

FIG. 12 shows a side view of another embodiment of the ligation clip.

FIG. 13 shows a side view of an embodiment of the ligation clip havingjaws with crossed clamping portions.

FIG. 14 shows a perspective view of a length of ribbon wire.

FIG. 15 shows a perspective view of a length of round wire.

DETAILED DESCRIPTION OF THE INVENTION INCLUDING A BEST MODE Nomenclature

-   -   10 Ligation Clip (First Embodiment)    -   12 First Jaw    -   14 Second Jaw    -   16 Clamping Portion (First Jaw)    -   18 Clamping Portion (Second Jaw)    -   20 Flexing Portion (First Jaw)    -   22 Flexing Portion (Second Jaw)    -   24 a Distal End (First Jaw)    -   24 b Distal End (Second Jaw)    -   26 Proximal End    -   50 Clip System    -   52 Cannula    -   54 Cannula Wall    -   56 Lumen    -   58 Distal End of Cannula    -   60 Push Rod    -   62 Clip Lock    -   100 Ligation Clip (Second Embodiment)    -   112 First Jaw    -   114 Second Jaw    -   116 Clamping Portion (First Jaw)    -   118 Clamping Portion (Second Jaw)    -   120 Flexing Portion (First Jaw)    -   122 Flexing Portion (Second Jaw)    -   126 Proximal End    -   200 Ligation Clip (Third Embodiment)    -   212 First Jaw    -   214 Second Jaw    -   216 Clamping Portion (First Jaw)    -   218 Clamping Portion (Second Jaw)    -   220 Flexing Portion (First Jaw)    -   222 Flexing Portion (Second Jaw)    -   224 a Distal End (First Jaw)    -   224 b Distal End (Second Jaw)    -   226 Proximal End    -   300 Ligation Clip (Fourth Embodiment)    -   312 First Jaw    -   314 Second Jaw    -   316 Clamping Portion (First Jaw)    -   318 Clamping Portion (Second Jaw)    -   320 Flexing Portion (First Jaw)    -   322 Flexing Portion (Second Jaw)    -   324 a Distal End (First Jaw)    -   324 b Distal End (Second Jaw)    -   326 Proximal End    -   328 Weld    -   330 Fitting    -   332 Pusher    -   352 Cannula    -   354 Cannula Wall    -   356 Lumen    -   358 Distal End of Cannula    -   400 Ligation Clip (Fifth Embodiment)    -   412 First Jaw    -   414 Second Jaw    -   416 Clamping Portion (First Jaw)    -   417 a Grips (First Jaw)    -   417 b Grips (Second Jaw)    -   418 Clamping Portion (Second Jaw)    -   420 Flexing Portion (First Jaw)    -   422 Flexing Portion (Second Jaw)    -   424 a Distal End (First Jaw)    -   424 b Distal End (Second Jaw)    -   426 Proximal End    -   500 Ligation Clip (Sixth Embodiment)    -   512 First Jaw    -   514 Second Jaw    -   516 Clamping Portion (First Jaw)    -   518 Clamping Portion (Second Jaw)    -   520 Flexing Portion (First Jaw)    -   524 a Distal End (First Jaw)    -   524 b Distal End (Second Jaw)    -   526 Proximal End    -   600 Ligation Clip (Seventh Embodiment)    -   612 First Jaw    -   614 Second Jaw    -   616 Clamping Portion (First Jaw)    -   617 Indentation (First Jaw)    -   618 Clamping Portion (Second Jaw)    -   620 Flexing Portion (First Jaw)    -   624 a Distal End (First Jaw)    -   624 b Distal End (Second Jaw)    -   626 Proximal End    -   800 Ligation Clip (Eighth Embodiment)    -   812 First Jaw    -   814 Second Jaw    -   816 Clamping Portion (First Jaw)    -   818 Clamping Portion (Second Jaw)    -   820 Flexing Portion (First Jaw)    -   822 Flexing Portion (Second Jaw)    -   824 a Distal End (First Jaw)    -   824 b Distal End (Second Jaw)    -   826 Proximal End    -   910 Ribbon Wire    -   912 Round Wire    -   914 D-Shaped Wire    -   V Vessel

Construction

FIG. 1 shows a first embodiment of the ligation clip 10. The ligationclip 10 comprises at least a first 12 and second jaw 14, which have alongitudinal orientation. The first jaw 12 defines a clamping portion 16and a flexing portion 20, and the second jaw 14 similarly defines aclamping portion 18 and a flexing portion 22. In this embodiment, theclamping portions 16, 18 are parallel with each other and should contactor nearly contact each other when in a non-stressed state. Both first 12and second 14 jaws define a distal end 24 a, 24 b, which are notconnected together and therefore able to be separated from each other. Aproximal end 26 is likewise defined longitudinally opposite the distalend 24 a, 24 b, however, at the proximal end 26 the first 12 and second14 jaws are attached. The attachment may take the form of the entireclip 10, 100, 200, 300, 400, 500, 600, 800 being formed from a singlelength of wire as shown in FIGS. 1-11 and FIGS. 13-14. Alternatively,the attachment may be two separate pieces of wire 312, 314 held togetherby a welded joint 328 and a threaded sleeve 330 as shown in FIG. 12. Asshown in FIGS. 1-2, and 5-14, the flexing portions 20, 22, 120, 122,320, 322, 420, 422, 520, 620, 820, 822 are formed so as to have bendswith substantially straight portions extending away from thelongitudinal axis of the first and second 12, 14, 112, 114, 212, 214,312, 314, 412, 414, 512, 514, 612, 614, 812, 814 jaws. The inventioncontemplates other angles for the flexing portions 20, 22, 120, 122,320, 322, 420, 422, 520, 620, 820, 822, thus, other angles can also beformed so as to create different angular relationships to thelongitudinal axis of the first 112 and second 114 jaws. An angulardifference also necessitates a difference in the ratio of the length ofthe flexing portions 20, 22, 120, 122, 320, 322, 420, 422, 520, 620,820, 822 to the clamping portions 16, 18, 116, 118, 216, 218, 316, 318,416, 418, 516, 518, 616, 618, 816 and 818.

In a second embodiment, as shown in FIG. 3, the ligation clip 100comprises at least a first 112 and second jaw 114, which have alongitudinal orientation. The first jaw 112 defines a clamping portion116 and a flexing portion 120. The second jaw 114 similarly defines aclamping portion 118 and a flexing portion 122. In this embodiment, theclamping portions 116, 118 are parallel with each other and shouldcontact each other when in a non-stressed state. As discussed above, theflexing portions 120, 122 define a different angle than shown in theembodiment of FIG. 1. Both first 112 and second 114 jaws define distalends, 124 a, 124 b, which are not connected together and therefore ableto separate. A proximal end 126 is likewise defined longitudinallyopposite the distal ends 124 a, 124 b, however, at the proximal end 126the first 112 and second 114 jaws are attached.

A third embodiment of the ligation clip 200 is shown in FIG. 4, whereinthe flexing portions 220, 222 are formed in a curved manner. In allother aspects, the third embodiment of the ligation clip 200 isstructurally and functionally similar to the embodiments shown in FIGS.1-3 and 5-8. A first jaw 212 defines a clamping portion 216 whichterminates at a distal end (not shown) and a flexing portion 220. Asecond jaw 214 defines a clamping portion 218 which terminates at adistal end (not shown) and a flexing portion 222. The clamping portion216 of the first jaw 212 when unstressed is parallel with and contactsor nearly contacts the clamping portion 218 of the second jaw 214. Thefirst 212 and second 214 jaws are joined together at a proximal end 226.FIG. 4 a shows a cross-section taken along line A-A of the clampingportions 216, 218 of the third embodiment 200 to illustrate “D” shapedwire. Other wire shapes including ribbon wire as shown in FIG. 15, roundwire as shown in FIG. 16 and third round (120 degree) wire (not shown)are also contemplated by and therefore within the scope of theinvention.

Several additional embodiments of the ligation clip are also disclosedin the specification. FIG. 9 illustrates a fourth embodiment of the clip400 which is similar to the embodiment 10 shown in FIG. 1 except thatthe clamping portions 416, 418 are provided with a series of wave-likegrips 417 a, 417 b to facilitate clamping. The grips 417 a, 417 b may beformed into the wire so as to be matching to further increase theclamping ability of the clip 400, however including this feature willincrease the complexity and cost of manufacturing due to greatermanufacturing precision involved. The ligation clip 400 defines at leasta first 412 and second jaw 414, which have a longitudinal orientation.The first jaw 412 defines a clamping portion 416 and a flexing portion420. The second jaw 414 similarly defines a clamping portion 418 and aflexing portion 422. In this embodiment, the clamping portions 416, 418should contact each other or nearly so when in a non-stressed state.Both first 412 and second 414 jaws define distal ends, 424 a, 424 b,which are not connected together and therefore able to separate. Aproximal end 426 is likewise defined longitudinally opposite the distalend 424 a, 424 b, however, at the proximal end 426 the first 412 andsecond 414 jaws are attached.

FIG. 10 shows a fifth embodiment of the clip 500 which is similar to theclip 10 of FIG. 1 except for the lack of a flexing portion on the secondjaw 514. This necessitates a longer clamping section 518 on the secondjaw 514. The effect of only a single flexing portion 520 is to lessenthe amount of force exerted by the clip 500 as a result of clamping. Theligation clip 500 defines at least a first 512 and second jaw 514, whichhave a longitudinal orientation. The first jaw 512 defines a clampingportion 516 and a flexing portion 520. The second jaw 514, however,defines a only a clamping portion 518. In this embodiment, the clampingportions 516, 518 are parallel with each other and should contact eachother or nearly so when in a non-stressed state, only along that portionof their lengths where the clamping portion 516 of the first jaw 512corresponds with the clamping portion 518 of the second jaw 514. Bothfirst 512 and second 514 jaws define distal ends, 524 a, 524 b, whichare not connected together and therefore separate. A proximal end 526 islikewise defined longitudinally opposite the distal end 524 a, 524 b,however, at the proximal end 526 the first 512 and second 514 jaws areattached.

FIG. 11 shows a sixth embodiment of the clip 600, which is similar tothe clip 500 shown in FIG. 10. The difference is that the clip 600 hasan indentation 617 in the clamping portion 616 of the first jaw 612. Theindentation 617 allows the clip 600 to exert less force against theclamped anatomical structure should less force be necessary. Anadditional advantage to having an indentation 617 is that it may help toguide or seat the structure and prevent the structure to be clamped (notshown) from being forced out of the clip 600 during the clampingprocedure. The ligation clip 600 defines at least a first 612 and secondjaw 614, which have a longitudinal orientation. The first jaw 612defines a clamping portion 616 and a flexing portion 620. The second jaw614, however, defines only a clamping portion 618. In this embodiment,the clamping portions 616, 618 should contact at least a portion of eachother or nearly so when in a non-stressed state. Both first 612 andsecond 614 jaws define a distal end 624 a, 624 b, which are notconnected together and therefore able to separate. A proximal end 626 islikewise defined longitudinally opposite the distal ends 624 a, 624 b,however, at the proximal end 626 the first 612 and second 614 jaws areattached.

FIG. 13 shows a seventh embodiment of the clip 800 that defines a firstjaw 812 and a second jaw 814. The first jaw 812 defines a clampingportion 816 which terminates at a distal end 824 a and a flexing portion820. In a similar manner, the second jaw 814 defines a clamping portion818, which terminates at a distal end 824 b and a flexing portion 822.The first jaw 812 and second jaw 814 are joined at a proximal end 826 ofthe clip 800. The clamping portions 816, 818 cross over each other so asto exert a greater amount of force against a clamped anatomicalstructure (not shown in FIG. 13).

In a preferred embodiment, the clip 10, 100, 200, 300, 400, 500, 600,800 is formed from a single length of nitinol wire that has beenprocessed to exhibit superelasticity at human body temperature (around37 degrees C.). The invention also contemplates forming the clip 10,100, 200, 300, 400, 500, 600, 800 from nitinol processed to exhibitthermal shape memory characteristics at human body temperature. Nitinolis an approximate stoichiometric alloy of nickel and titanium, however,other elements such as vanadium, are sometimes added in small amounts toalter the mechanical characteristics of the alloy. Its chemicalcomposition and its processing history primarily determine theparticular mechanical properties of a shape memory/superelastic metallicalloy. In general, such an alloy will exist in either one or the other,or combinations of two crystallographic phases. Austenite is the parentcrystallographic phase and exists at higher temperatures. Martensite isthe other phase and it is formed by either subjecting the alloy to lowertemperatures or by placing mechanical or physical stress on the alloywhile it is in the austenitic phase. Transition temperatures betweenthese two phases can be experimentally determined for a particularalloy. Alloy chemistry and thermo-mechanical forming of the alloy areprimarily responsible for determining the alloy's characteristics.Processing history, including high temperature annealing as well as lowtemperature forming and deformation, also play a role in determining thecrystallographic phase of the material. Following standard material andprocessing specifications, the transitional temperatures which definethe alloy's mechanical characteristics are predictable and controllable.Standard transitional temperature designations are given as: M, for thestart of the transition to the martensitic phase, M_(f) for completionof the transition to martensite, A, for the start of the transition tothe austenitic phase, and Af for the completed transition to austenite.Making the clip 10, 100, 200, 300, 400, 500, 600, 800 fromnon-superelastic materials such as stainless steel or spring steel isalso contemplated by and therefore within the scope of the invention.

Superelasticity is also based on phase transition from austenite tomartensite. Phase transition from austenite to martensite occurs whenthe alloy temperature is above Af and a physically restraining stress isapplied to the alloy. As long as the restraint is in place, the portionof the alloy which is receiving the stress reverts to the martensiticphase, which remains as long as the stress is maintained. Unless theshape recovery limits are exceeded, when the stress is released thealloy returns to its original austenitic phase and shape as long as thetemperature is maintained above Af. Thus, when the austenitic, trainedshape of the alloy is deformed and held by stress in a new shape, acertain amount of force is exerted by the alloy against the restraint asit resists the new, untrained shape. Similarly, following release of therestraint, should an object prevent the alloy from completely returningto its trained, austenitic shape (assuming the temperature is somewhereabove A_(s)), the alloy will exert a certain amount of force against theobject. This is another aspect of superelasticity and is caused by thetemporary, stress induced formation of martensite which will revert backto austenite upon release of the restraint.

The thermal shape memory effect of these alloys has been known muchlonger than superelasticity. Thermal shape memory occurs as the resultof a piece of shape memory alloy metal being deformed while in the lowertemperature martensitic phase and then being reheated to a highertemperature which causes they alloy to reform in the austenitic phase.When the crystallographic nature of the alloy is completely austenitic,the alloy's shape returns to the shape prior to being deformed while inthe martensitic phase. Shape memory training occurs when a shapememory/superelastic metallic alloy is annealed (heat treated) whilerestrained in a certain shape. The trained shape will then be maintainedunless it is deformed while in the low temperature martensitic phase.Upon reheating the alloy to the austenitic phase, the original shapewhich was “learned” in the annealing process will be “remembered” andreturned to. Thus, temperature change is one way of controlling thecrystallographic phase of a shape memory/superelastic metallic alloy.

One practical advantage of a shape memory/superelastic alloy overnon-superelastic materials is that it is able to be deformed to a fargreater degree without taking a permanent set or kink. In the case ofsuperelastic alloys (i.e., alloys processed to exhibit superelasticityat body temperature), assuming the alloy is above the A_(s) temperature,removal of the restraint alone is sufficient to resume the original,trained shape. When the alloy is processed to have shape memorycharacteristics, the martensitic phase alloy need only be subjected totemperatures somewhere above A_(s) and the alloy will eventually returnto its original, trained shape. It is also possible to use a restraintin conjunction with alloys trained to exhibit thermal shape memorycharacteristics.

Thus, when the clip 10, 100, 200, 300, 400, 500, 600, 800 is processedto exhibit superelastic characteristics at human body temperature, ituses superelasticity in two different ways. First, superelasticity(stress-induced martensite) allows the clip 10, 100, 200, 300, 400, 500,600, 800 to be deformed to a degree sufficient to enable it to be loadedinto a surgical cannula 52, 352, without taking a permanent set or kink.While the clip 10, 100, 200, 300, 400, 500, 600, 800 is restrainedwithin the lumen 56, 356 by the cannula walls 54, 354, assuming the clip10, 100, 200, 300, 400, 500, 600, 800 is maintained at a temperatureabove A_(s), the portions (unnumbered) of the clip 10, 100, 200, 300,400, 500, 600, 800 contacting the lumen 56, 356 are exerting an amountof force against the cannula walls 54, 354 due to the formation ofstress-induced martensite. The loaded cannula 52, 352 can then beintroduced into the patient's body (not shown) through a small incision(not shown) following which the clip 10, 100, 200, 300, 400, 500, 600,800 can be advanced from the distal end 58, 358 of the cannula 52, 352.Using non-invasive, minimally invasive, endoscopic or laparoscopictechniques, the physician is able to view the internal procedure. Usingthe push rod 60 and clip lock 62, the jaws 12, 14, 112, 114, 212, 214,312, 314, 412, 414, 512, 514, 612, 614, 812, 814 of the clip 10, 100,200, 300, 400, 500, 600, 800 are gradually advanced from the distal end58, 358 of the cannula 52, 352. The clip 10, 100, 200, 300, 400, 500,600, 800 can then be deployed around a suitable anatomical structure Vto clamp or ligate the structure V. As explained below, the forceexerted by the deployed clip 10, 100, 200, 300, 400, 500, 600, 800against the clamped anatomical structure V is also a function ofsuperelasticity (stress-induced martensite), due to the presence of theanatomical structure V between the jaws.

A further superelastic phenomenon affects the performance of theclamping ability of the clip. Superelastic nitinol is unusual in that anincreased amount of stress applied to a certain point does not obeyHooke's law, which predicts an increased proportional correspondingamount strain to be exerted by the alloy. Instead, hysteresis isexhibited as a result of the formation of stress-induced martensite,where a stress plateau is formed as a result of increased strain. Putanother way, a larger structure requires an increased amount ofdeflection of the jaws 12, 14, 112, 114, 212, 214, 312, 314, 412, 414,512, 514, 612, 614, 812, 814 to be able to surround the structure (notshown). By using superelastic nitinol, the amount of force exerted bythe clip 10, 100, 200, 300, 400, 500, 600, 800 is approximately the sameas if a relatively small structure (not shown) is being clamped. Thepractical effect of this phenomenon is that the amount of clamping forceis programmable and predictable as a result of the thermo-mechanicalprocessing of the alloy. Thus, a clip 10, 100, 200, 300, 400, 500, 600,800 can be designed which is programmed to exert only the amount offorce necessary to complete the clamping procedure, but which is knownto be below an amount that would damage the clamped tissue. Furthercontrol over the amount of force exerted by the clip 10, 100, 200, 300,400, 500, 600, 800 can be adjusted by altering mechanical parameterssuch as wire diameter, and additional shape parameters such as size andangle of the flexing portions 20, 22, 120, 122, 320, 322, 420, 422, 520,620, 820, 822. Having a “coiled spring” section (not shown) around theproximal end 26, 126, 226, 426, 526, 626 and 826 is an additional designparameter that could be used to control the amount of force exhibited bythe clip 10, 100, 200, 300, 400, 500, 600, 800 and is thereforecontemplated by and within the scope of the invention.

When the clip 10, 100, 200, 300, 400, 500, 600, 800 is formed to exhibitshape memory characteristics at body temperature, the A_(s) must beprogrammed into the alloy to be somewhere below human body temperature.The clip 10, 100, 200, 300, 400, 500, 600, 800 is loaded into a surgicalcannula 52, 352 at a temperature somewhere above A_(s) as describedabove. Alternatively, the clip 10, 100, 200, 300, 400, 500, 600, 800 canbe cooled to a temperature below M_(f) to place the clip 10, 100, 200,300, 400, 500, 600, 800 in the martensitic phase prior to loading. Whenthe loaded cannula 52, 352 is being inserted into the body (not shown),means must be used to maintain the temperature of the clip below A_(s).Typically, a cold saline drip (not shown) is maintained through thelumen 56, 356 during the insertion procedure. Following arrival of theloaded cannula 52, 352 at the treatment site within the patient's body,the clip 10, 100, 200, 300, 400, 500, 600, 800 is advanced from thedistal end 58, 358 of the cannula whereupon it is exposed to bodytemperature, which is above the A_(s) of the alloy. Exposure to bodytemperature raises the temperature of the alloy to a point where theunstressed portions of the clip 10, 100, 200, 300, 400, 500, 600, 800are in the austenitic phase, returning the clip 10, 100, 200, 300, 400,500, 600, 800 toward its original, trained shape.

Making the clip 10, 100, 200, 300, 400, 500, 600, 800 involves acquiringa sufficient length of nitinol wire (not shown) and securely installingit in a jig (not shown) having stops (not shown) matching the contoursof the desired finished, trained shape. Wire of varying diameters andshapes (e.g., rectangular (not shown), half round (not shown), fullround 912, ribbon 910 or D-shaped 914) is heated at various temperaturesand lengths of time due to differences in size and metallurgy anddesired mechanical performance. The wire (not shown) is then cooled byvarious methods depending on the desired finished characteristics.Finally, the distal ends 24 a, 24 b, 124 a, 124 b, 224 a, 224 b, 324 a,324 b, 424 a, 424 b, 524 a, 524 b, 624 a, 624 b, 824 a, 824 b of theclip 10, 100, 200, 300, 400, 500, 600, 800 are preferably rounded orblunt, however, sharp tips may also be required in some cases requiringpuncturing of tissue as part of a procedure. It should mentioned thatwire having a relatively high porosity (i.e., not polished or oxided) ispreferable due to its improved ultrasonography characteristics. It isalso contemplated by and therefore within the scope of the invention toroughen the surface of the clip 10, 100, 200, 300, 400, 500, 600, 800 toimprove the ultrasonography characteristics. Where grippability iscritical, it possible to create teeth (not shown) on the surfaces of theclamping portions 16, 18, 116, 118, 216, 218, 316, 318, 416, 418, 516,518, 616, 618, 816 and 818.

Use

Using the clip 10, 100, 200, 300, 400, 500, 600, 800 involves firstloading the clip 10, 100, 200, 300, 400, 500, 600, 800 into a surgicalcannula 52, 352. The term surgical cannula 52, 352 as used here isgeneric and refers to any tubular structure defining a lumen used togain access to remote sites in a patient's body, such as a needle,catheter, sheath or other delivery system. Depending on the type ofcannula 52, 352 used, the clip 10, 100, 200, 300, 400, 500, 600, 800 canbe loaded into either the proximal end (not shown) or the distal end 58,358 of the cannula 52, 352. The finally loaded clip system 50 is bestshown in FIG. 5. Regardless of which end of the cannula 52, 352 is usedfor loading, the clip 10, 100, 200, 300, 400, 500, 600, 800 is insertedso the distal ends 24 a, 24 b, 324 a, 324 b, 424 a, 424 b, 524 a, 524 b,624 a, 624 b, 824 a, 824 b exit first from the distal end 58, 358 of thecannula 52, 352 following advancement.

Following loading of the cannula 52, 352, the clip system 50 isnavigated to the remote treatment site (not shown) in the patient'sbody, using well known techniques. Using non-invasive, minimallyinvasive, endoscopic or laparoscopic techniques the physician is able tovisualize the treatment site. Upon determining the anatomical structureto be clamped, the physician uses the push rod 60 and clip lock 62 whichare attached to a mechanical stop system (not shown) to preciselyadvance the distal ends 24 a, 24 b, 324 a, 324 b, 424 a, 424 b, 524 a,524 b, 624 a, 624 b, 824 a, 824 b of the clip 10, 100, 200, 300, 400,500, 600, 800 from the distal end 58, 358 of the cannula 52, 352.Advancing the clip 10, 100, 200, 300, 400, 500, 600, 800 a very smalldistance while visualizing the procedure, the clamping portions 16, 18,116, 118, 216, 218, 316, 318, 416, 418, 516, 518, 616, 618, 816, 818 ofthe jaws 12, 14, 112, 114, 212, 214, 312, 314, 412, 414, 512, 514, 612,614, 812, 814 upon being released from the confines of the cannula 52,352 extend away from the cannula 52, 352 as best shown in FIG. 6. Theclamping portions 16, 18, 116, 118, 216, 218, 316, 318, 416, 418, 516,518, 616, 618, 816, 818 of the jaws 12, 14, 112, 114, 212, 214, 312,314, 412, 414, 512, 514, 612, 614, 812, 814 extend in this direction dueto the continued compression of the flexing portion of the jaws 20, 22,120, 122, 220, 222, 320, 322, 420, 422, 520, 620, 820, 822 by the lumen56, 356 of the cannula 52, 352. The open configuration of the clampingportions 16, 18, 116, 118, 216, 218, 316, 318, 416, 418, 516, 518, 616,618, 816, 818 allows the physician to position the clamping portions 16,18, 116, 118, 216, 218, 316, 318, 416, 418, 516, 518, 616, 618, 816, 818of the clip 10, 100, 200, 300, 400, 500, 600, 800 around the anatomicalstructure V to be clamped. When the anatomical structure V to be clampedis surrounded, the physician further advances the clip 10, 100, 200,300, 400, 500, 600, 800 from the cannula 52, 352, eventually resultingin the flexing portions of the jaws 20, 22, 120, 122, 220, 222, 320,322, 420, 422, 520, 620, 720, 820, 822 being released from the lumen 56,356 of the cannula 52, 352 and thereby being decompressed. As best shownin FIG. 7, decompression results in the clamping portions 16, 18, 116,118, 216, 218, 316, 318, 416, 418, 516, 518, 616, 618, 816, 818attempting to resume their original, trained, austenitic phaseconfiguration. The clamping portions 16, 18, 116, 118, 216, 218, 316,318, 416, 418, 516, 518, 616, 618, 816, 818, however, are prevented fromcompletely closing due to the presence of the clamped anatomicalstructure V being clamped by the clamping portions 16, 18, 116, 118,216, 218, 316, 318, 416, 418, 516, 518, 616, 618, 816, 818. This isresults in the formation of stress-induced martensite, which suppliesthe force exerted by the clip 10, 100, 200, 300, 400, 500, 600, 800against the anatomical structure. Finally, the clip lock 62 is releasedas shown in FIG. 8.

Repositioning the clip 10, 100, 200, 300, 400, 500, 600, 800, prior torelease from the clip lock 62, is a relatively easy procedure. Using thepush rod 60, the physician draws the flexing portions of the jaws 20,22, 120, 122, 220, 222, 320, 322, 420, 422, 520, 620, 820, 822 back intothe lumen 56, 356 until the clamping portions 16, 18, 116, 118, 216,218, 316, 318, 416, 418, 516, 518, 616, 618, 816, 818 are again spreadapart as best shown in FIG. 6. This allows the physician to repositionthe clip 10, 100, 200, 300, 400, 500, 600, 800 over another anatomicalsite, and repeat the procedure described above.

1. A clip system for application to mammalian tissue, comprising: aneedle including a bore that extends longitudinally to a distal openingof the needle, the distal opening being deliverable to a targetedinternal tissue; and a clip device that superelastically deforms to alateral dimension smaller than an inner dimension of the needle bore sothat the entire clip device advances into the needle bore for deliveryout of the distal opening of the needle, the clip device including: afirst clamping arm and a second clamping arm opposing the first clampingarm and being biased toward the first clamping arm, the first and secondclamping arms including proximal portions that abut against one anotherand distal ends that are movable away from one another, and a flexinghead coupled to proximal ends of the first and second clamping arms, theflexing head being adjustable between a first shape in which the firstand second clamping arms extend generally parallel to one another and astressed shape in which at least the distal ends of the first and secondclamping arms are spaced apart while the proximal portions of the firstand second clamping arms abut against one another, wherein the needleengages the flexing head to releasably retain the flexing head in thestressed shape when the entire clip device is disposed in the needlebore and, in response to the clip device being advanced distally out ofthe distal opening of the needle, the flexing head adjusts toward thefirst shape so that the first and second clamping arms shift toward oneanother to provide a clamping force.
 2. The clip system of claim 1wherein the flexing head comprises a first flexing section coupled tothe proximal portion of the first clamping arm and a second flexingsection coupled to the proximal portion of the second clamping arm, thefirst flexing section of the clip device mirrors the shape of the secondflexing section relative to a longitudinal axis.
 3. The clip system ofclaim 2 wherein the first clamping arm is aligned with the secondclamping arm along the longitudinal axis so that the first clamping armcontacts the second clamping arm without crossing over the longitudinalaxis.
 4. The clip system of claim 1 wherein the clip device comprises asingle wire that defines the first jaw and the second jaw, the wirehaving a cross-sectional shape in a lateral plane of the clip device. 5.The clip system of claim 4 wherein the cross-sectional shape in thelateral plane is D-shaped.
 6. The clip system of claim 1 wherein theclip device is configured to engage an anatomical structure when thefirst and second clamping arms shift toward one another.
 7. The clipsystem of claim 1 wherein the proximal portions of the first clampingarm and the second clamping arm abut against one another at a heelportion when the flexing head is in the stressed shape.
 8. The clipsystem of claim 7 wherein the distal ends of the first clamping arm andthe second clamping arm comprise blunt tips.
 9. The clip system of claim1 wherein the clip device comprises a material that exhibitssuperelasticity characteristics at a temperature of about 37 degrees C.,the flexing head exhibiting superelasticity characteristics when theflexing head returns toward the first shape after being deformed to thestressed shape while the entire clip device is disposed in the needlebore.
 10. The clip system of claim 1 further comprising a push rodmovably disposed in the needle bore to deliver the clip device distallyfrom the needle bore and out of the distal opening.
 11. The clip systemof claim 1 wherein the first clamping arm comprises wave-shaped gripsthat are matable with complementary wave-shaped grips of the secondclamping arm.
 12. The clip system of claim 11 wherein the wave-shapedgrips facilitate engagement with the targeted internal tissue betweenthe first and second clamping arms.
 13. The clip system of claim 1wherein the first clamping arm comprises an indentation that at leastpartially defines a gap between the first clamping arm and the secondclamping arm.
 14. The clip system of claim 13 wherein the gap that is atleast partially defined by the indentation provides a seat structurethat retains the targeted internal tissue engaged between the first andsecond clamping arms.
 15. The clip system of claim 1 wherein in the clipdevice comprises a superelastic alloy material that is mechanicallyprocessed to provide a predetermined clamping force between the firstand second clamping arms.
 16. The clip system of claim 15 wherein thepredetermined clamping force is selected to provide a force that issufficient to clamp the targeted internal tissue between the first andsecond clamping arms and that is below a threshold force to damage thetargeted internal tissue.
 17. A clip system for application to mammaliantissue, comprising: a needle including a bore that extends along alongitudinal axis to a distal opening of the needle, the distal openingbeing deliverable to a targeted internal tissue; and a clip device thatsuperelastically deforms to a lateral dimension smaller than an innerdimension of the needle bore so that the entire clip device advancesinto the needle bore for delivery out of the distal opening of theneedle, wherein the clip device is formed of a single wire having across-sectional shape that is D-shaped, the clip device including: afirst clamping arm and a second clamping arm opposing the first clampingarm and being biased toward the first clamping arm, the first and secondclamping arms including heel portions that abut against one another anddistal ends that are movable away from one another, wherein the firstclamping arm is aligned with the second clamping arm along thelongitudinal axis so that the first clamping arm contacts the secondclamping arm without crossing over the longitudinal axis, and a flexinghead coupled to proximal ends of the first and second clamping arms, theflexing head being adjustable between a first shape in which the firstand second clamping arms extend generally parallel to one another and astressed shape in which at least the distal ends of the first and secondclamping arms are spaced apart while the heel portions of the first andsecond clamping arms abut against one another, wherein the needleengages and compresses the flexing head to releasably retain the flexinghead in the stressed shape when the entire clip device is disposed inthe needle bore.
 18. The clip system of claim 17 wherein, in response tothe clip device being advanced distally out of the distal opening of theneedle, the flexing head shifts toward the first shape so that the firstand second clamping arms shift toward one another to provide a clampingforce.
 19. The clip system of claim 18 wherein the clip device comprisesa material that exhibits superelasticity characteristics at atemperature of about 37 degrees C., the flexing head exhibitingsuperelasticity characteristics when the flexing head returns toward thefirst shape after being deformed to the stressed shape while the entireclip device is disposed in the needle bore.
 20. The clip system of claim19 further comprising a push rod movably disposed in the needle bore todeliver the clip device distally from the needle bore and out of thedistal opening.